Neuropsychological Characterization of Patients With Bipolar Disorder and a History of Suicide Attempt

NCT ID: NCT02116400

Last Updated: 2016-05-24

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-07-31

Brief Summary

The main objective of this study is to evaluate decision-making using the Iowa Gambling Task (IGT) among patients with euthymic bipolar disorder according to their personal history of suicide attempt ("suicidal" vs. "not suicidal ").

Detailed Description

The secondary objectives of this study are:

A. Evaluate other aspects of cognitive functioning (using the Tower of London, the Probabilistic Reversal-learning task, the Rey Complex Figure, the Reading the Mind in the Eyes test) in euthymic patients with bipolar disorder, depending on the presence or absence of a history of suicide attempt; B. Explore performance on neuropsychological tests depending on the type of therapy administered (lithium salts or valproate monotherapy or in combination with other mood stabilizers); C. Explore a possible relationship between circulating levels of lithium or sodium divalproex results and different neuropsychological tests; D. Establishment of a biobank for this population with leftover blood samples following serum lithium or divalproex testing.

Conditions

Bipolar Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Suicidal

Patients in this group have had suicidal behaviour according to the C-SSRS score.

Intervention: Interview Intervention: Neuropsychological testing Intervention: Serum concentration of lithium or sodium divalproate.

Interview

Intervention Type: OTHER

All patients are interviewed at the BEC. Questionnaires and scores are administered. See endpoints.

Neuropsychological testing

Intervention Type: OTHER

Neuropsychological tests are administered (requires computer use). See endpoints.

Serum concentration of lithium or sodium divalproate.

Intervention Type: BIOLOGICAL

Venous blood is drawn and tested for serum concentration of lithium or sodium divalproate.

Not suicidal

Patients in this group have not had suicidal behaviour according to the C-SSRS score.

Intervention: Interview Intervention: Neuropsychological testing Intervention: Serum concentration of lithium or sodium divalproate.

Interview

Intervention Type: OTHER

All patients are interviewed at the BEC. Questionnaires and scores are administered. See endpoints.

Neuropsychological testing

Intervention Type: OTHER

Neuropsychological tests are administered (requires computer use). See endpoints.

Serum concentration of lithium or sodium divalproate.

Intervention Type: BIOLOGICAL

Venous blood is drawn and tested for serum concentration of lithium or sodium divalproate.

Interventions

Interview

All patients are interviewed at the BEC. Questionnaires and scores are administered. See endpoints.

Intervention Type: OTHER

Neuropsychological testing

Neuropsychological tests are administered (requires computer use). See endpoints.

Intervention Type: OTHER

Serum concentration of lithium or sodium divalproate.

Venous blood is drawn and tested for serum concentration of lithium or sodium divalproate.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• The patient was correctly informed about the study
• The patient must be insured or beneficiary of a health insurance plan
• The diagnosis of bipolar disorder is confirmed by the doctor referring the patient to the BEC and confirmed during the preliminary interview at the BEC
• The patient is euthymic on the day of inclusion. This is supported by a short psychiatric interview conducted at the BEC and the completion of the depression and mania scales (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire).
• The patient is prescribed a mood stabilizer based on lithium or divalproex.

• The patients withdraws consent during the study
• The patient does not understand directions necessary for the neurpsychological tasks
• The patient is not able to use a computer to complete the neuropsychological tasks

Exclusion Criteria

• The patient is under judicial protection, under tutorship or curatorship
• The patient formalizes his/her opposition to the studyd
• It is impossible to correctly inform the patient
• The patient has mental retardation
• The patient has practiced substance abuse or dependence within the 6 months prior to study inclusion (alcool, cannabis, opiates, psychostimulants)
• The patient does not meet euthymic criteria (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabienne Cyprien, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU de Nîmes - Hôpital Universitaire Carémeau

Other Identifiers

2012-A01673-40

Identifier Type: OTHER

Identifier Source: secondary_id

AOI/2012/FC-02

Identifier Type: -

Identifier Source: org_study_id